End-Stage Kidney Disease, Hemodialysis
Conditions
Keywords
Normal saline, Destrose 5%, Blood pressure, Interdialytic weight gain, thirst level, End Stage Renal Failure
Brief summary
This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period. The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.
Interventions
DRUGDextrose 5%
DRUGnormal saline
Sponsors
Ministry of Health, Malaysia
Penang Hospital, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime. * Have regular hemodialysisforat least 6 months or more. * Willing and able to provide written, signed informed consent after the nature of the study has been explained. * Willing and able to comply with all study procedures. * Age ≥18 years; Age \< 75 years old
Exclusion criteria
* Diabetes mellitus, Malignancy, Pregnancy * Inability or unwillingness to provide written consent. * Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator. * Simultaneous participation in another clinical study except observational trials * Any psychological condition which could interfere with the patient's ability to comply with the study protocol * Inability to perform a blood pressure measurement on the upper limb * Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period. * Life expectancy \< 6 months * Recent acute myocardial infarction, congestive cardiac failure, stroke, angina or ICU admission within last 6 months, * Planned to migrate/move out of the city * Alcohol abuse/ drug abuse within last 6 months * Missed \> 2 hemodialysis sessions over 1 month * Requiring non- cuff catheter for hemodialysis * Admitted for major infection within the last one month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| systolic blood pressure control | Time from week 0 until week 12 | post intervention systolic blood pressure reduction compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interdialytic weight gain | Time from week 0 until week 12 | reduced Interdialytic weight gain in experimental group |
| thirst level | Time from week 0 and week 12 | Dialysis thirst inventory questionnaire to be administer by patient at baseline (week 0) and end of trial (week 12) |
| intradialytic event | Time from week 0 until week 12 | Any incident occuring during hemodialysis treatment which needed medical intervention. The event are chills and rigor, chest pain, giddiness, cramps, vomiting, blood loss and hypotension. |
| adverse events | Time from week 0 until week 12 | All observed or spontaneously reported adverse events occur during the trial period. |
Countries
Malaysia
Contacts
Primary ContactLoke Meng Ong, FRCP
Outcome results
None listed